Understanding ISO 13485:2016 Training for Medical Devices, Documenting ISO 13485:2016 for Medical Devices Quality Management Systems
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Understanding and Documenting ISO 13485:2016 for Medical Devices Quality Management Systems

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Seminar Content

Omnex is an Exemplar Global certified training provider and offers this 1.5 day course under the TPECS scheme meeting the knowledge competency requirements for Medical Devices Management Systems that can be applied to all auditor grades. This seminar fully covers the ISO 13485:2016 requirements. ISO 13485 specifies requirements for quality management systems in order to achieve regulatory compliance in the medical device sector.

Many medical device companies are utilizing ISO 13485 as a platform to build their business management systems because of its value or because third party certification is a specified requirement by customers and/or regulators.

This class also covers the comparable 21 CFR 820 content for additional guidance for organizations in the Medical Device sector.

Attendees who successfully demonstrate competence during this course will achieve a Certificate of Attainment for the following competency units:

  • Exemplar Global-MD

Who Should Attend

This seminar is designed for Quality Assurance Practitioners, Managers, ISO 13485:2016 Implementation Team Members and Management Representatives.

Recommended Training and/or Experience

A general understanding of quality management systems and a minimum of 3 months of relevant experience is recommended.

Seminar Materials

Each participant will receive a seminar manual.

Seminar Goals

  • Understand the application of Quality Management Principles in the context of ISO 13485:2016.
  • Relate the quality management system to the organization’s medical devices, and provision of related services

Seminar Outline

Day One

  • Introduction and Welcome
    • Chapter 1 – Introduction to ISO 13485
    • Chapter 2 – The ISO 13485 Standard Explained
      • MD Written Exercise 1 (individual)
    • Chapter 3 – Overview of ISO 13485:2016 Requirements
      • MD Written Exercises 2a, 2b (Audit Scenarios)

Day Two

  • Overview of ISO 13485:2016 Requirements (cont’d)
    • Breakout Exercise 2c (Audit Scenarios)
    • MD Written Exercise 3 (individual)

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ISO 13485 Training Resources

ISO 13485:2016 Internal Auditor Training

ISO 13485:2016 Lead Auditor Training

ISO 13485:2016 for Top Management

ISO 13485:2003 Internal Auditor Training

ISO 13485:2003 Lead Auditor Training

Understanding ISO 13485:2003 Training

Role of Top Management in ISO 13485:2003